The Central Government has amended the Drugs Rules, 1945, to strengthen the regulation of High Alcohol-Containing Drug Formulations. The Ministry of Health and Family Welfare has removed the existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol.

According to the notification issued by the Ministry of Health and Family Welfare, all formulations containing more than 12 percent volume per volume ethyl alcohol, in quantities exceeding 30 millilitres, will no longer be covered under the exemption provided to them under Schedule K. Such products will be required to obtain the requisite licenses under the Drugs and Cosmetics Act, 1940.

Earlier, certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, had been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945. Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80 to 90 percent volume per volume, making them susceptible to misuse for intoxication.

The amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain. It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use.